| Primary | Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis | Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release. | A wound drain was not inserted in all patients - hence why wound blood was not able to be collected 4 hours post tourniquet release. | Posted | | Mean | Standard Deviation | ug/L | | 4 hours after tourniquet release | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| | | Title | Denominators | Categories |
|---|
| Systemic PAP blood level 4 HR post TQR | - ParticipantsOG00031
- ParticipantsOG00132
| |
| |
| Secondary | Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation | Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release | | Posted | | Mean | Standard Deviation | pmol/L | | before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of Tranexamic Acid | | Blood was collected from the A-Line or CostaVac Drain. If no drain was placed, the wound 4 hour post TQR blood could not be collected. | Posted | | Mean | Standard Deviation | mg/L | | Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Calculated Postoperative Blood Loss | | | Posted | | Median | Inter-Quartile Range | mL | | Duration of inpatient hospital stay (average of 3 days) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of Hemoglobin | | The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw. | Posted | | Mean | Standard Deviation | g/dL | | 1 hour after tourniquet release, POD 1, POD 2 | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of Hematocrit | | The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw. | Posted | | Mean | Standard Deviation | % of red blood cells in blood | | 1 hour after tourniquet release, POD 1, POD 2 | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Constavac Blood Drainage | A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir. | Some patients did not get a contavac drain put in hence the discrepancy in analysis population description. | Posted | | Median | Inter-Quartile Range | mL | | 4 hours after tourniquet release | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
|
| Secondary | Incidence of Thrombosis (DVT/PE) | | | Posted | | Count of Participants | | Participants | | Postoperative day 14 (2 weeks after surgery) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Patients Who Had 1 Unit of Blood Transfusion Administered | | | Posted | | Count of Participants | | Participants | | Duration of inpatient hospital stay (average of 3 days) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Time to Physical Therapy Discharge | | | Posted | | Median | Inter-Quartile Range | days | | During Hospital Stay | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Length of Hospital Stay | | | Posted | | Median | Full Range | days | | Length of Hospital Stay | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of IL-6 in Blood | | | Posted | | Mean | Standard Deviation | pg/mL | | Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis | Levels of PAP will be measured in peripheral blood and wound drainage | | Posted | | Mean | Standard Deviation | mg/L | | Intraoperative, 1 hour post Tourniquet Release (TQR) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
| |
| Secondary | Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood | The values for the wound blood levels are given as the count of patients who had a level above the threshold of >3600 pmol/L. | Blood samples could not be collected at the 4-hour post tourniquet release for some patients. | Posted | | Count of Participants | | Participants | | Intraoperative, 4 hour post Tourniquet Release (TQR) | | | | ID | Title | Description |
|---|
| OG000 | Intravenous Tranexamic Acid | Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline | | OG001 | Topical Tranexamic Acid | Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline |
|